DERMA E SUN PROTECTION MINERAL SPF 30- zinc oxide powder

Derma E Sun Protection Mineral by

Drug Labeling and Warnings

Derma E Sun Protection Mineral by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc., Aopline Health Industry Technology (Guangzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 24.1%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply throughout the day
• Children under 6 months of age: Ask a doctor
• Sun Protection Measures
  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

Inactive ingredients

Silica, Mica, Aluminum Starch Octenyl Succinate, Triethoxyoctylsilane, Magnesium Stearate, Stearic Acid, CI 77491, Phenoxyethanol, CI 77492, Bisabolol, Tocopherol, Ethylhexylglycerin, Isostearyl Alcohol, Ceramide NP.

Other information

• protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by DERMA E®
Simi Valley, CA 93065, USA

PRINCIPAL DISPLAY PANEL - 5 g Bottle Box

CLINICALLY TESTED

DERMA E
Proven
Clean
Beauty™

NEW & IMPROVED
NEW & IMPROVED

DERMA E
ESSENTIALS

Sun Protection
Mineral Powder

Zinc Oxide & Ceramides

broad spectrum UVA/UVB
translucent finish for
all skin tones

spf
30

0.16 OZ / 5 g

INGREDIENTS AND APPEARANCE

DERMA E SUN PROTECTION MINERAL   SPF 30
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-1486
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	241 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
CERAMIDE NP (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-1486-1	1 in 1 BOX	02/26/2024
1		5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	02/26/2024

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Aopline Health Industry Technology (Guangzhou) Co., Ltd.		715076108	MANUFACTURE(54108-1486)